CORONUR RETARD 40 mg PROLONGED-RELEASE COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Coronur retard 40 mg prolonged-release tablets

Isosorbide mononitrate

In this leaflet:

1. What Coronur retard is and what it is used for
2. Before taking Coronur retard
3. How to take Coronur retard
4. Possible side effects
5. Storage of Coronur retard
6. Further information

1. What Coronur retard is and what it is used for

Coronur retard contains isosorbide mononitrate as the active substance, which belongs to a group of medicines known as nitrates that have vasodilating properties of the coronary arteries of the heart (arteries that irrigate the heart muscle).

This medicine is indicated for the treatment and prevention of angina pectoris (chest pain and feeling of oppression in the chest that occurs when not enough blood reaches the heart).

2. Before taking Coronur retard

Do not take Coronur retard

• if you are allergic (hypersensitive) to isosorbide mononitrate, isosorbide dinitrate, or any of the other components of Coronur retard,
• in case of shock (potentially life-threatening effect that occurs when the body does not receive enough blood, which can damage multiple organs), cardiocirculatory collapse (paralysis of blood circulation), very low blood pressure (maximum less than 90 mm Hg), or acute myocardial infarction (heart attack),
• if you have severe anemia, cerebral trauma, or cerebral hemorrhage,
• if you are taking any medicine that contains a 5-phosphodiesterase inhibitor such as sildenafil (medicine used for erectile dysfunction).

Be careful with Coronur retard

• consult your doctor if you have any of the following diseases: hypertrophic cardiomyopathy (heart disease characterized by thickening of the heart walls), constrictive pericarditis (inflammation of the heart lining), cardiac tamponade (compression of the heart due to blood or fluid accumulation), mitral and/or aortic stenosis of the heart, orthostatic disorders of circulatory regulation (feeling of dizziness when standing up), or increased intracranial pressure.
• Coronur retard is not suitable for the treatment of sudden angina attacks; your doctor may have prescribed another medicine for these cases.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Due to the possibility of potentiation of the hypotensive effect (decrease in blood pressure), caution should be exercised when administering Coronur retard with antihypertensive medicines (medicines that reduce high blood pressure, e.g., calcium antagonists, beta-blockers, diuretics, angiotensin-converting enzyme inhibitors), vasodilators, neuroleptic drugs (medicines for the treatment of mental illnesses), or tricyclic antidepressants (medicines for depression).

With alcohol, in addition to hypotension, the decrease in reaction capacity may be accentuated.

Nitrates can give false negatives (results that should be positive but are negative due to error) in cholesterol determination reactions in blood by the Zlatkis-Zak method.

Coronur retard may increase the hypertensive effect of dihydroergotamine (medicine used for headache).

The concomitant administration of Coronur retard with 5-phosphodiesterase inhibitors such as sildenafil (medicine used for erectile dysfunction) may lead to life-threatening heart complications in sensitive individuals.

Taking Coronur retard with food and drinks

Do not take this medicine with alcohol, as it potentiates the vasodilating effect of isosorbide mononitrate, which can lead to a rapid decrease in blood pressure.

The tablets should be taken after meals without chewing and with a large amount of liquid (a glass of water).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Coronur retard should not be taken during pregnancy, unless, in the strict opinion of the doctor, the benefit justifies the potential risks.

Coronur retard should not be used during breastfeeding, as it is unknown whether it passes into breast milk.

Use in children

The use of Coronur retard is not recommended in children because its safety and efficacy have not been established in this population.

Driving and using machines

Observe your response to the medication, as it may reduce your ability to drive vehicles or use machines due to a decrease in your reflexes, especially at the start of treatment, when changing the dose, or if you also consume alcohol. Therefore, avoid driving or using potentially hazardous machinery until you verify how you tolerate the medicine.

Important information about some of the components of Coronur retard

This medicine contains lactose, glucose, and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Athletes are informed that this medicine contains a component that may result in a positive doping control test.

3. How to take Coronur retard

Follow exactly the administration instructions of Coronur retard tablets indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The normal dose of Coronur retard is one tablet (40 mg of isosorbide mononitrate), once a day in the morning or at night before bedtime if your doctor has recommended it because you have crises at night.

The tablets should be taken after meals without chewing and with a large amount of liquid (a glass of water).

In patients not accustomed to treatment with nitrates, and to prevent or minimize possible headache, at the start of treatment, your doctor will recommend starting with a low dose (e.g., half a Coronur 20 mg tablet, twice a day), which will be gradually increased later.

If you think the effect of Coronur retard is too strong or too weak, tell your doctor or pharmacist.

During therapy with Coronur, tolerance (decrease in effect) may develop. It is recommended to maintain the dose as low as possible and allow the maximum possible time interval between doses to recover sensitivity (first dose in the morning and last dose at the end of the afternoon).

It is advisable to take this medicine while sitting, especially at the beginning of treatment, if you are taking high doses, or if you are over 65 years old.

It is important to start and stop treatment with Coronur retard gradually and never abruptly. Your doctor will indicate the way to gradually increase and reduce the dose.

Your doctor will indicate the duration of your treatment with this medicine. Do not stop treatment before, as it could lead to a sudden increase in blood pressure.

If you take more Coronur retard than you should

If you have taken more Coronur retard than you should, consult your doctor or pharmacist immediately.

The main symptoms in case of intoxication are: headache, decrease in blood pressure with dizziness when standing up, tachycardia (increased heart rate), and cyanosis (bluish discoloration of the skin due to insufficient oxygenation of the blood).

It is recommended to keep the patient lying down with their legs elevated to correct the drop in blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Coronur retard

Do not take a double dose to make up for forgotten doses.

Take the tablet at the moment you remember on that day and continue with the usual dose.

4. Possible side effects

Like all medicines, Coronur retard can cause side effects, although not everybody gets them.

During the use of Coronur retard, the following side effects have been observed, whose frequency could not be established with accuracy.

In certain cases, especially with high doses or at the start of treatment, orthostatic hypotension (dizziness when standing up) may occur. In particularly sensitive patients, hypotension can lead to syncope (fainting), which could be confused with the symptoms of a heart attack.

Occasionally, and especially when used for the first time, gastrointestinal disorders such as nausea and/or vomiting may appear.

In patients with a history of coronary artery disease (narrowing of the arteries that supply the heart), ischemia (temporary or permanent reduction of blood flow) may occur.

In patients with methemoglobin reductase deficiency or abnormal hemoglobin structure, a blood disorder (methemoglobin formation) may occur, resulting in lower oxygen content in the blood, which can cause bluish discoloration of the skin and mucous membranes, headache, fatigue, difficulty breathing, and lack of energy.

Rarely, it can cause skin rashes and/or exfoliative dermatitis (peeling of the skin).

Other side effects are: headache, flushing or feeling of facial heat, dizziness, palpitations, fatigue. Generally, all these effects, including hypotension, disappear with continued treatment or, in any case, with a decrease in the dose.

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of Coronur retard

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Coronur retard after the expiration date stated on the packaging after "EXP.". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Further information

Composition of Coronur retard

• The active substance of Coronur retard is isosorbide mononitrate.
• The other components are: In the core: anhydrous lactose, wax E, povidone K25, anhydrous colloidal silica, and magnesium stearate. In the coating: sucrose, methacrylic acid copolymer, talc, heavy kaolin, macrogol 35000, titanium dioxide, glucose liquid, wax E, povidone K25.

Appearance of the product and packaging content

Coronur retard is presented in the form of round, white tablets.

Coronur retard is presented in packages of 30 tablets.

Other presentations

Coronur 20 mg tablets

Coronur 40 mg tablets

Marketing authorization holder and manufacturer

KERN PHARMA, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

This leaflet was last revised

January 2010